Cytokinetics (CYTK) said Monday that the European Medicines Agency has validated its marketing authorization application for aficamten as as potential treatment for obstructive hypertrophic cardiomyopathy.
The application will now be reviewed by the agency's Committee for Medicinal Products for Human Use.
The application is supported by the results of a 24-week phase 3 clinical trial wherein patients treated with the drug candidate showed "significantly improved exercise capacity," compared with a baseline and "statistically significant improvements" in all 10 secondary endpoints, the company said.
The agency's validation follows the drug's application acceptance by the US Food and Drug Administration for the same indication, the company said.
Hypertrophic cardiomyopathy is an illness in which the heart muscle becomes abnormally thick, limiting the heart's pumping function and leading to reduced physical capacity.
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